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Melatonin and Radiation Therapy in Treating Patients With Brain Metastases
This study has been completed.
First Received: March 8, 2002   Last Updated: August 29, 2009   History of Changes
Sponsor: Radiation Therapy Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00031967
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as melatonin may make tumor cells more sensitive to radiation therapy and may protect normal cells from the side effects of radiation therapy.

PURPOSE: Randomized phase II trial to determine the effectiveness of combining melatonin with radiation therapy in treating patients who have brain metastases.


Condition Intervention Phase
Metastatic Cancer
Radiation Toxicity
Unspecified Adult Solid Tumor, Protocol Specific
 Drug: therapeutic melatonin
Radiation: radiation therapy
 Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: A Randomized Phase II Study of A.M. and P.M. Melatonin for Brain Metastasis in RPA Class II Patients

Resource links provided by NLM:

MedlinePlus related topics: Cancer
Drug Information available for: Melatonin
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: May 2002
Detailed Description:

OBJECTIVES:

  • Determine the effect of melatonin, used as radiosensitization/radioprotection, on overall survival and clinical deterioration in patients with brain metastases who are undergoing radiotherapy.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to planned chemotherapy after whole brain irradiation (yes vs no). Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo whole brain irradiation once daily 5 days a week for 2 weeks. Patients receive oral melatonin once daily every morning.
  • Arm II: Patients undergo whole brain irradiation as in arm I. Patients receive oral melatonin once daily every evening.

All patients continue on melatonin for 6 months in the absence of disease progression or unacceptable toxicity.

Patients are followed at months 6 and 12 from start of radiotherapy and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 128 patients (64 per treatment arm) will be accrued for this study within 5 months.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed solid tumor with brain metastasis

    • No germ cell tumors

  • RPA class II with any of the following:

    • At least 65 years of age
    • Extracranial metastases
    • Uncontrolled primary malignancy
  • Ineligible for or unwilling to participate in alternative RTOG stereotactic radiosurgery studies

PATIENT CHARACTERISTICS:

Age:

  • See Disease Characteristics

Performance status:

  • Zubrod 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • Able to swallow pills
  • Not pregnant
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • More than 30 days since prior chemotherapy
  • Concurrent chemotherapy after whole brain irradiation allowed

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • No prior radiotherapy to the brain

Surgery:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00031967

  Show 234 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Lawrence B. Berk, MD, PhD Newark Radiation Oncology
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:
Berk L, Berkey B, Rich T, Hrushesky W, Blask D, Gallagher M, Kudrimoti M, McGarry RC, Suh J, Mehta M. Randomized phase II trial of high-dose melatonin and radiation therapy for rpa class 2 patients with brain metastases (RTOG 0119). Int J Radiat Oncol Biol Phys. 2007 Apr 5; [Epub ahead of print]
Berk L, Seiferheld W, Rich T, et al.: RTOG BR-0119: Chronobiological study of the addition of melatonin to radiotherapy for brain metastases. [Abstract] Neuro-Oncology 6 (4): RT-01, 359, 2004.

Study ID Numbers: CDR0000069245, RTOG-BR-0119, RTOG-DEV-1013
Study First Received: March 8, 2002
Last Updated: August 29, 2009
ClinicalTrials.gov Identifier: NCT00031967     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific
tumors metastatic to brain
radiation toxicity

Additional relevant MeSH terms:
Antioxidants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Central Nervous System Depressants
Protective Agents
Pharmacologic Actions
Neoplastic Processes
 Neoplasms
Pathologic Processes
Therapeutic Uses
Neoplasm Metastasis
Melatonin
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009



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